Prescription drug · ANDA
Desloratadine NDC 68180-153
Desloratadine 5 mg/1 · Tablet, Film coated · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-153-01 | 6818001530168180015301 | 100 TABLET, FILM COATED in 1 BOTTLE (68180-153-01)Marketed from Feb 25, 2013 | |
| 68180-153-02 | 6818001530268180015302 | 500 TABLET, FILM COATED in 1 BOTTLE (68180-153-02)Marketed from Feb 25, 2013 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Desloratadine
- Generic name (nonproprietary)
- desloratadine
- Active ingredients
- Desloratadine — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078352
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68180-153_4b7fefd7-7d54-400c-a7b4-b3fc4ada2eb1SPL ID 4b7fefd7-7d54-400c-a7b4-b3fc4ada2eb1SPL set ID 2a90b899-7746-43dc-ac8a-e754428eb30cRxCUI 349420UNII FVF865388RUPC 0368180153023
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468180015301followed by a unit qualifier and the quantityPackage 68180-0153-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Desloratadine tablets are histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.1 ) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.2 ) 1.1 Seasonal Allergic Rhinitis Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. 1.2 Perennial Allergic Rhinitis Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older.…
Excerpt only. Read the full label for complete information.
About NDC 68180-153
- What is NDC 68180-153?
- 68180-153 is the product NDC for Desloratadine, Desloratadine 5 mg/1 tablet, film coated, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Desloratadine.
- What is the active ingredient?
- Desloratadine.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Desloratadine?
- 11 other product NDCs are listed under this name. See all Desloratadine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Desloratadine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | Morepen Bio Inc. | 87717-001 | 87717-0001-0187717-0001-02 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | Natco Pharma USA LLC | 69339-194 | 69339-0194-0169339-0194-05 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-363 | 69452-0363-2069452-0363-30 |
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-3975 | 50090-3975-0050090-3975-01 |
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | Virtus Pharmaceuticals, LLC | 69543-107 | 69543-0107-1069543-0107-50 |
| Desloratadine | Desloratadine 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2308 | 72162-2308-0172162-2308-0372162-2308-05 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4794 | 50090-4794-00 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6724 | 50090-6724-00 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1000 | 71335-1000-0171335-1000-0271335-1000-03 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Orally disintegratingOral | Dr. Reddy's Laboratories Limited | 55111-360 | 55111-0360-0655111-0360-31 |
Other NDCs under ANDA 078352
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4794 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6724 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1000 |